Study of Heat Shock Protein-Peptide Complex (HSPPC-96) Versus IL-2/DTIC for Stage IV Melanoma
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The primary goal of this study is to determine if people with metastatic melanoma who receive Heat Shock Protein-Peptide Complex - 96 (HSPPC-96 or Oncophage) after surgery live longer than people who may or may not have surgery but who receive conventional chemotherapy including IL-2/DTIC. A second goal is to determine the safety and frequency of side effects in subjects who receive therapy with HSPPC-96.
Condition or disease
Drug: HSPPC-96 or Oncophage
To determine whether subjects with stage IV melanoma randomized to HSPPC-96 have longer survival than subjects randomized to physician's choice including interleukin-2 and/or dacarbazine/temozolomide and/or complete tumor resection.
To determine frequency of adverse events in subjects randomized to HSPPC-96.
A Phase III Study of Heat Shock Protein-Peptide Complex (HSPPC-96) Versus Physician's Choice Including Interleukin-2 and/or Dacarbazine/Temozolomide-based Therapy and/or Complete Tumor Resection in Stage IV Melanoma
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
(The following assessments must be obtained within three weeks prior to randomization into the study)
Medical history and physical examination (including EGOG score, evidence of immunosuppression);
CT/MRI of the chest, abdomen and pelvis;
CT/MRI of the brain;
Complete Blood Count with differential including platelets;
Electrolytes (Na, Cl, K, HCO3, Ca, Mg, PO4);
Renal function tests (BUN and creatinine);
Liver function tests (bilirubin, AST, ALT);
Serum pregnancy test for all women of childbearing potential.
Stage IV Melanoma (AJCC);
No prior therapy for stage IV melanoma;
No prior therapy with interleukin-2 and/or dacarbazine/temozolomide within the past 12 months prior to study entry;
Candidate for surgical resection of some/all sites of melanoma and expected to obtain greater tan or equal to 7 grams of viable cancer tissue (in aggregate), which is equivalent to a greater than or equal to 2 cm lesion on CT/MRI or clinical examination;
No brain metastases;
ECOG score 0 or 1;
Adequate cardiac function;
Adequate hematopoietic, liver and renal function;
Female subjects of child-bearing potential must agree to use contraception during the study
Signed written informed consent.
Mucosal or ocular melanomas;
Other malignancies treated within the last five years, except in situ cervix carcinoma or non-melanoma skin cancer;
Primary or secondary immunodeficiency, in the opinion of the investigator (including immunosuppressive disease, or use of systemic corticosteroids or other immunosuppressive medications);
Uncontrolled infection or other serious medical illnesses;
Women who are pregnant or breast-feeding;
Subjects participating in any other studies requiring administration of an investigational drug/biologic agent.